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IRCT20260523069506N1 IRCT 2026-05-30 Tehran University of Medical Sciences High-Power Laser versus Ultrasound for Pain Management in Bilateral TMD: A Comparative Study" Comparison of the Effects of High-Power Laser Therapy and Ultrasound on Pain Reduction in Patients with Bilateral Temporomandibular Disorders (TMD): A single-blind randomized clinical trial 2026-06-05 anticipated 15 Recruiting https://irct.ir/trial/90304 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Blinding description: To maintain patient blinding, the type of intervention on each side of the jaw will not be recognizable to the patient, and the conditions for applying the two treatments in terms of feel, positioning, and probe contact will be made similar for both sides. N/A Temporomandibular Disorders. Intervention 1: First intervention group: First group (high-power laser): The G (Novinmed, Iran) Laser 885 device will be used with the following parameters: Pulsed mode, Peak power = 5 W; Average power = 1.5 W, applicator area 16 cm² :(area), Target dose: 30 J/cm² for the treatment area (based on the area of ​​16 cm², it is equivalent to 480 J of total energy to the area. Radiation time (calculation): According to the relationship Energy (J) = Average power (W) × time (s), the time required to deliver 480 J with an average power of 1.5 W is 5 minutes. Treatment method: The applicator is moved in a scan (continuous movement) over the mandibular ramus area and the area around the TMJ to cover the treatment area. Safety: Simultaneous use of protective glasses for the patient and the operator, recording the feeling of heat/burning before and after each session, recording and reporting any complications (redness, blisters, increased pain) and stopping the treatment if necessary. Intervention 2: Second intervention group: Second group (ultrasound): Ultrasound 215M (Novinmed, Iran) will be used with the following parameters: Frequency: 1 MHz, Intensity: 1.5 W/cm2, Mode: Continuous, Time: 5 minutes for each side. Treatment method: The probe with appropriate gel is moved in gentle circular motions over the masseter and temporal muscles to cover the entire treatment area. Safety: Continuous movement of the probe, use of sufficient gel, stop if you feel any unusual pain or discomfort, and record any complications. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A decision on the publication of these data will be made later, depending on the country's domestic laws as well as the conditions of foreign journals for publishing articles.
public Mohamad javad Seidi
No.1 ,salehi Ave.,jamalzadeh Blvd.,Tehran town
Tehran Iran (Islamic Republic of) 1416173554 +98 21 2238 1695 Javad.seidy3440@gmail.com Tehran University of Medical Sciences scientific Mohamad javad Seidi
No.1 ,salehi Ave.,jamalzadeh Blvd.,Tehran town
Tehran Iran (Islamic Republic of) 1416173554 +98 21 2238 1695 Javad.seidy3440@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Adults aged 18 years and older. Bilateral temporomandibular joint pain with a minimum intensity of 3 on the Visual Analog Scale (VAS). All temporomandibular joint disorders that result in pain in the TMJ capsule region, regardless of the underlying etiology, will be included in the study. Symptoms present for at least 3 months (chronicity ≥ 3 months Diagnosis of TMD established by an orofacial pain specialist / oral and maxillofacial specialist according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). 18 years no limit Both Presence of advanced degenerative joint disease (DJD) or osteoarthritis in the TMJ as evidenced by radiographic imaging. History of trauma or surgery in the temporomandibular joint region within the past 6 months. Active systemic or rheumatic diseases. Pregnancy Receiving or having received physiotherapy treatment for TMD. M26.6 Temporomandibular joint disorders Treatment - Other Treatment - Other First intervention group: First group (high-power laser): The G (Novinmed, Iran) Laser 885 device will be used with the following parameters: Pulsed mode, Peak power = 5 W; Average power = 1.5 W, applicator area 16 cm² :(area), Target dose: 30 J/cm² for the treatment area (based on the area of ​​16 cm², it is equivalent to 480 J of total energy to the area. Radiation time (calculation): According to the relationship Energy (J) = Average power (W) × time (s), the time required to deliver 480 J with an average power of 1.5 W is 5 minutes. Treatment method: The applicator is moved in a scan (continuous movement) over the mandibular ramus area and the area around the TMJ to cover the treatment area. Safety: Simultaneous use of protective glasses for the patient and the operator, recording the feeling of heat/burning before and after each session, recording and reporting any complications (redness, blisters, increased pain) and stopping the treatment if necessary. Second intervention group: Second group (ultrasound): Ultrasound 215M (Novinmed, Iran) will be used with the following parameters: Frequency: 1 MHz, Intensity: 1.5 W/cm2, Mode: Continuous, Time: 5 minutes for each side. Treatment method: The probe with appropriate gel is moved in gentle circular motions over the masseter and temporal muscles to cover the entire treatment area. Safety: Continuous movement of the probe, use of sufficient gel, stop if you feel any unusual pain or discomfort, and record any complications. Pain level based on the Visual Analogue Scale scale. Timepoint: Assessments include pain intensity (Visual Analogue Scale) and are measured at three stages (before treatment, end of treatment, and one month afterward). Method of measurement: Using the Visual Analogue Scale. Tehran University of Medical Sciences Approved 2026-05-19 Ethics Committee, Faculty of Dentistry, Tehran University of Medical Sciences End of North Kargar Street, next to the Atomic Energy Organization, before reaching the Hakim Shargh Highway exit, Faculty of Dentistry, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)